Clinical trial · Interventional
Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
A Phase 2, Multicenter, Open-label, Single-arm Study of Valemetostat Tosylate (DS-3201b) in Patients With Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
NCT04102150CI-TRIAL-00085700completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This Phase 2 study will be conducted to assess the efficacy and safety of valemetostat tosylate (DS-3201b) in participants with relapsed or refractory adult T-cell leukemia/lymphoma (r/r ATL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult T-cell Leukemia/Lymphoma | Adult T-Cell Leukemia/Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Valemetostat Tosylate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DS-3201b
- interventionNames
- Drug: Valemetostat Tosylate
Primary outcomes (1)
- measure
- Overall response rate (ORR) assessed by central evaluation organization
- timeFrame
- Through the end of the study (within approximately 5 years)
- description
- The percentage of participants who were assessed for best overall response, who achieved complete remission (CR), complete remission, unconfirmed (CRu) or partial remission (PR) by central evaluation organization.
Secondary outcomes (8)
- measure
- Overall response rate (ORR) assessed by investigator
- timeFrame
- Through the end of the study (within approximately 5 years)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with relapsed or refractory adult T-cell leukemia/lymphoma (ATL) who have history of treatment with mogamulizumab or are mogamulizumab intolerant, contraindication after treatment with at least 1 medication regimen * Aged ≥20 years or older at the time of signing the informed consent * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 * At least 1 evaluable lesion * Participants who have defined laboratory criteria * Life expectancy ≥ 3 months Exclusion Criteria: * A presence of central nervous system involvement at the time of screening tests * Have poorly controlled complication (eg. chronic congestive heart failure, unstable angina * ≥ Grade 3 neuropathy * QT interval corrected using Fridericia's method (QTcF) \>470 ms * Has an uncontrolled infection * Participants who use corticosteroids over 10 mg/day * Receipt of allogeneic hematopoietic stem cell transplantation * History of, or concurrent, malignant tumors
References
Publications (1)
- DERIVEDIzutsu K, Makita S, Nosaka K, Yoshimitsu M, Utsunomiya A, Kusumoto S, Morishima S, Tsukasaki K, Kawamata T, Ono T, Rai S, Katsuya H, Ishikawa J, Yamada H, Kato K, Tachibana M, Kakurai Y, Adachi N, Tobinai K, Yonekura K, Ishitsuka K. An open-label, single-arm phase 2 trial of valemetostat for relapsed or refractory adult T-cell leukemia/lymphoma. Blood. 2023 Mar 9;141(10):1159-1168. doi: 10.1182/blood.2022016862. PMID 36150143